Various bodily diseases and/or conditions, including, for example, tumors, aneurysms and varicose vein expansion, may be caused by malfunction or other problems associated with the veins or arteries that supply or remove blood to/from the treatment areas. For example, the venous system of the lower extremities includes the superficial (greater and lesser saphenous veins) and deep system (popliteal and femoral veins). These two parallel systems are interconnected via perforator veins. One-way valves are present at the junctions between the bifurcation point of the deep and superficial system, at the saphenofemoral and the saphenopopliteal junctions.
Larger varicose veins, e.g., tortuous veins measuring between 2 mm and 2 cm in diameter, and protruding above the surface of the skin, are typically related to valve incompetence either at the saphenofemoral or saphenopopliteal junction. As the venous pressure in the deep system is generally greater than that of the superficial system, valve incompetence leads to increased hydrostatic pressure transmitted to the unsupported superficial vein system, ultimately resulting in varicosities. Clusters of varicosities may appear at the site of perforating vessels, such as the perforating veins of Hunter and Dodd, located in the mid and distal thigh, respectively. This pattern of varicosity is typically associated with incompetence at the saphenofemoral junction.
In some instances, the valvular incompetence may be isolated to a perforator vein, such as the Boyd perforating vein located in the anteromedial calf. These varicosities are often not associated with saphenous vein incompetence since the perforating veins in the lower part of the leg do not communicate directly with the saphenous vein. Although many varicose veins are asymptomatic, symptoms including itching, heaviness, and pain may occur. In addition, varicose veins may be complicated by peripheral edema due to venous insufficiency, hemorrhage, thrombophlebitis, venous ulceration, and chronic skin changes.
Varicose veins are a common condition. In adult western populations visible varicose veins are present in 20-25% of women and 10-15% of men. In most persons, varicose veins do not cause symptoms other than poor cosmetics. Varicose vein surgery is one of the most commonly performed cosmetic procedures in the United States.
Most varicose veins do not require medical treatment (Tapley, et al. 2003). In some cases, however, the circulation may be hindered enough to cause swelling of the foot and ankle, discomfort, a tingling sensation, or a feeling of heaviness. For most people with varicose veins, wearing specially fitted elastic stockings is all that is needed. The stockings should be carefully fitted to the individual, providing the most pressure in the lowest part of the leg. Exercise such as walking or cycling also helps promote better circulation from the lower part of the body. Symptoms often decrease when the legs are elevated periodically, and when prolonged standing is avoided. Varicose veins can usually be treated with non-surgical measures.
When conservative treatment measures fail, additional treatment options typically focus first on identifying and correcting the site of reflux, and second on redirecting venous flow through veins with intact valves. Surgical treatment of varicosities may include controlling the most proximal point of reflux, typically at the saphenofemoral junction, as identified by preoperative Doppler ultrasonography. Surgical ligation and division of the saphenofemoral or saphenopopliteal junction is performed to treat the valvular incompetence. Another surgical treatment includes removal of the refluxing greater and/or lesser saphenous vein from the circulation. The most typical strategy for isolation is vein stripping, which is generally preceded by vein ligation and division. A further surgical treatment includes removal of the varicose tributaries. Strategies for removal include stab avulsion or injection sclerotherapy, either at the time of the initial treatment, or subsequently.
Over the years various different minimally invasive alternatives to ligation and stripping have been investigated, including sclerotherapy, endoluminal radiofrequency ablation and laser ablation. The objective of sclerotherapy is generally to destroy the endothelium of the target vessel by injecting an irritant solution (for example a detergent, osmotic solution, or a chemical irritant), ultimately resulting in the complete obliteration of the vessel. Too little destruction may lead to thrombosis without fibrosis and ultimate recanalization. Too much destruction may lead to vascular dehiscence. The success of the treatment may depend on accurate injection of the vessel, an adequate injectant volume and concentration of sclerosant, and post-procedure compression. Compression theoretically results in direct apposition of the treated vein walls to provide more effective fibrosis and may decrease the extent of the thrombosis formation. Therefore, due to technical limitations, larger veins and very tortuous veins may not be good candidates for sclerotherapy.
While sclerotherapy is an accepted and effective treatment of telangiectatic vessels, it has also been used in the treatment of varicose tributaries without prior ligation, with or without vein stripping. This application of sclerotherapy creates issues regarding its effectiveness in the absence of the control of the point of reflux and isolation of the refluxing saphenous vein. In addition, when the sclerosant is injected into the greater or lesser saphenous vein, sclerotherapy has been investigated as a minimally invasive alternative to vein stripping, either with or without ligation. Since the saphenous vein is not visible with the naked eye, injection is typically guided by ultrasonography, and the combined procedure may be referred to as “echosclerotherapy.” Since the greater saphenous vein is larger and deeper than telangiectatic dermal veins, sclerotherapy of this vein raises issues regarding appropriate volume and concentration of the sclerosant and the ability to provide adequate post-procedure compression. Moreover, the use of sclerotherapy, as opposed to the physical removal of the vein with stripping, raises the issue of recurrence due to recanalization.
McDonagh, et al. (2002, 2003) has reported on the effectiveness of ultrasound-guided foam sclerotherapy (comprehensive objective mapping, precise image-guided injection, antireflux positioning and sequential sclerotherapy (COMPASS) technique) in the treatment persons with varicosities of the greater saphenous vein with saphenous vein reflux. Published studies of the COMPASS technique involve relatively short-term follow up. Study subjects were followed for three years, and for only two years after completion of a series of repeat sclerotherapy injections that were administered over one year. In addition, these studies do not include a comparable group of subjects treated with surgery, which has been the primary method of treating incompetent long saphenous veins. Thus, definitive conclusions cannot be made about the durability of results of the COMPASS technique or its effectiveness compared with surgery for treatment of greater saphenous vein varicosities and saphenofemoral incompetence. In addition, published studies of the COMPASS technique come from a single group of investigators.
Published long-term randomized controlled clinical studies have demonstrated that surgery plus sclerotherapy is more effective than surgery alone for treatment of varicosities associated with incompetence of the saphenofemoral junction. Belcaro, et al. (2003) reported on the results from the Venous Disease International Control (VEDICO) trial, the first long-term randomized controlled clinical trial of foam sclerotherapy. The VEDICO trial involved 749 patients with varicose veins and saphenous vein incompetence who were randomly treated by six different approaches: standard sclerotherapy, high-dose sclerotherapy, surgical ligation, stab avulsion, foam sclerotherapy, and combined surgery (ligation or stab avulsion) and high dose sclerotherapy. At 10 years, the occurrence of new veins was 56% for standard sclerotherapy, 51% for foam sclerotherapy, 49% for high-dose sclerotherapy, 41% for stab avulsion, 38% for ligation, and 27% for combined surgery and sclerotherapy.
Belcaro, et al. (2000) reported on the results of a randomized controlled clinical study comparing ultrasound-guided sclerotherapy with surgery alone or surgery combined with sclerotherapy in 96 patients with varicose veins and superficial venous incompetence. Although all approaches were reported to be effective in controlling the progression of venous incompetence, surgery appeared to be the most effective method on a long-term basis, and that surgery combined with sclerotherapy may be more effective than surgery alone. After 10 years follow up, no incompetence of the saphenofemoral junction was observed in both groups assigned to surgery, compared to 18.8 percent of limbs of subjects assigned to ultrasound-guided sclerotherapy. Of limbs treated with ultrasound-guided sclerotherapy, 43.8% of the distal venous systems were incompetent, compared to 36% of limbs of subjects treated with surgery alone, and 16.1% of limbs of subjects treated with surgery plus sclerotherapy.
In recent years, new methods such as ES (endovascular sclerotherapy) and foam sclerotherapy (using ultrasound guidance) have been developed and proposed to improve the safety and efficacy of sclerotherapy for various types of varicose veins. Evidence about these new techniques for treating patients with incompetence of the long saphenous vein is limited, and the place of sclerotherapy as the first treatment for larger varicose veins (saphenous or non-saphenous) remains controversial.
Endoluminal radiofrequency ablation and laser ablation (e.g. VNUS® Closure™ System, Dornier Diode (Medilas D) and Diomed 810 nm surgical laser and EVLT (endovenous laser therapy)) have been investigated as minimally invasive alternatives to vein ligation and stripping. Both radiofrequency energy and laser therapy are similarly designed to damage the intimal wall of the vessel, resulting in fibrosis and ultimately obliteration of a long segment of the vein. Radiofrequency ablation is generally performed by means of a specially designed catheter inserted through a small incision in the distal medial thigh to within 1-2 cm of the saphenofemoral junction. High frequency radio waves (200-300 kHz) are delivered through the catheter electrode and cause direct heating of the vessel wall, causing the vein to collapse. The catheter is slowly withdrawn, closing the vein. Laser ablation is performed similarly. In the case of endoluminal laser therapy, a bare tipped laser fiber is introduced into the greater saphenous vein under ultrasound guidance; the laser is activated and slowly removed along the course of the saphenous vein.
Such catheters may generally treat veins with diameters that range from 2 to 12 mm. Each catheter may have a microthermocouple to monitor vein wall temperature. In practice, the catheter with its electrodes sheathed, is passed either prograde or retrograde through a venipuncture or through direct surgical exposure of the saphenous vein. The catheter position may be confirmed by ultrasound imaging, and exsanguination of the vein may be accomplished by external elastic wrapping (Esmarch bandaging) or large-volume, very dilute local anesthesia (tumescent technique).
Perhaps the most serious complication of varicose vein surgery, or other vein blockage surgery, is deep venous thrombosis with or without pulmonary embolization. In a number of early reports of varicose vein surgery and minimally invasive endoluminal therapy, the incidence of pulmonary embolization has ranged from 0.4% to 1. A less serious but troublesome complication is dysfunction in the territory of the greater saphenous nerve. This was found in 12.5% of limbs treated by endoluminal therapy.
Subfascial endoscopic perforator vein surgery (SEPS) is a minimally invasive endoscopic procedure that eliminates the need for a large incision in the leg. It has been explored as an alternative to the traditional open surgical treatment of chronic venous insufficiency. The aim of the procedure is to interrupt incompetent medial calf perforating veins to reduce venous reflux and decrease ambulatory venous hypertension in critical areas above the ankle where venous ulcers most frequently develop. Kalra and Gloviczki (2002) stated that available evidence confirmed the superiority of SEPS over open perforator ligation, but do not address its role in the surgical treatment of advanced chronic venous insufficiency (CVI) and venous ulceration. Ablation of superficial reflux by high ligation and stripping of the greater saphenous vein with avulsion of branch varicosities is concomitantly performed in the majority of patients undergoing SEPS. The clinical and hemodynamic improvements attributable to SEPS thus are difficult to ascertain. As with open perforator ligation, clinical and hemodynamic results are better in patients with primary valvular incompetence (PVI) than in those with the post-thrombotic (PT) syndrome.
Contraindications for SEPS include associated arterial occlusive disease, infected ulcer, a non-ambulatory patient, and a medically high-risk patient. Diabetes, renal failure, liver failure, morbid obesity, ulcers in patients with rheumatoid arthritis, or scleroderma, and presence of deep vein obstruction at the level of the popliteal vein or higher on pre-operative imaging are relative contraindications. Patients with extensive skin changes, circumferential large ulcers, recent deep vein thrombosis, severe lymphedema, or large legs may not be suitable candidates (Kalra and Gloviczki, 2002).
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